Comparison of a Protective Cough Syrup Against Placebo on Night Cough in Children 1-5 Years Coughing Since 1- 2 Days Due to Common Cold
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|ClinicalTrials.gov Identifier: NCT03218696|
Recruitment Status : Not yet recruiting
First Posted : July 14, 2017
Last Update Posted : January 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cough Acute Upper Respiratory Tract Infection||Device: Cough Syrup for adults and children Device: Placebo||Not Applicable|
Cough is a life saving reflex, therefore it is important, especially in pediatrics, to calm cough spells without sedating the reflex. Looking into mechanisms for cough management different from mucolytics, or sedatives, such as protection of irritated pharynx mucosa from post nasal drip or other irritating substances is theoretically sound and shows practical interesting results. A parallel comparison of efficacy and tolerability between such protective mechanism (acting through a barrier and radical scavenging action) due to natural substances (honey, plantago lanceolata and thymus vulgaris) and placebo has been looked at specifically on the clinically critical population of children coughing since 1-2 days and not more, including very young children of one year old. The intent of this study is to use the protective syrup versus placebo in children with moderate to severe night and daily cough, measured with a validated parent questionnaire. Daily cough is assessed to better describe and select the general condition of the child however only night cough parameters due to treatment are assessed. The degree of disturbance of cough is followed immediately after one night administration on all night parameters, with special interest to frequency.
Assessment of effectiveness of the protective cough syrup as compared to placebo is considered very interesting due to the mechanism of the remedy. The study looks at the effect of the syrup/placebo on the first night in order to well focus the "first" effect of a treatment on the ascending phase of the illness, such as to reduce to a minimum any interference due to natural regression of the symptom due to illness progression.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel randomized double blind|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||According to a predertermined list, the two products are provided in identical bottles and cartons appropriately labelled so as to ensure respect of the randomization list as well as blinding of all study participants.|
|Official Title:||A Randomized, Double-blind Study to Evaluate the Efficacy and Tolerability of a Cough Syrup Containing Specific Plant Extracts (Poliflav M.A.) and Honey Versus Placebo in Cough Due to Upper Respiratory Tract Infection|
|Estimated Study Start Date :||February 2018|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Cough Syrup for adults and children
CE Marked (authorized) medical device acting by protecting the oropharynx, in a non-pharmacological way, to reduce cough. It contains honey, plantago lanceolata, thymus vulgaris. Dosage form: syrup Dosage: 5 ml. Duration: one night
Device: Cough Syrup for adults and children
The intervention product is a medical device in Europe due to its non-pharmacological mode of action, which makes the product compliant to the medical device definition. It is made of specific extracts of plants (plantago and thymus) which provide the product with protective characteristics of the oropharynx. These protective features enable the syrup to reduce the irritative cough promoting stimuli on the throat, which decrease urge to cough threshhold. In addition to these extract, honey completes the formula. The product does not contain any artificial component and no preservatives.
Other Name: Poliflav M.A.-honey cough syrup
Placebo Comparator: Placebo
The placebo intervention is a similar syrup of taste and colour, with general protective components and other necessary synthetic components which may have an influence on cough, without the specific natural protective components. Dosage form: syrup. Dosage: 5 ml. Duration: one night
The placebo intervention is a syrup of same taste and colour without the natural protective components but with the necessary synthetic preservatives and other co-sweeteners to guarantee quality and safety. The placebo has, in fact, all the features of a cough syrup since true placebo syrup is not possible in cough. The lack of specific natural protective components is weighed against the presence of other necessary substances which may still have an effect on cough, but this effect is not envisaged to be a specific protective effect.
- Night cough frequency score reduction [ Time Frame: First and only night of treatment ]Night cough frequency is the most invasive element of distress to the child and family. The questionnaire rating night cough is filled in the morning following enrollment, relating to the passed night. The basal night score is the score of the night before enrollment.
- night cough intensity score reduction [ Time Frame: First and only night of treatment ]All these other elements constitute cough invasiveness into the quality of life of child and parents
- night cough bothersomeness score reduction [ Time Frame: First and only night of treatment ]All these other elements constitute cough invasiveness into the quality of life of child and parents
- reduction of influence of cough on child sleep score [ Time Frame: First and only night of treatment ]All these other elements constitute cough invasiveness into the quality of life of child and parents
- reduction of influence of cough on parent sleep score [ Time Frame: First and only night of treatment ]All these other elements constitute cough invasiveness into the quality of life of child and parents
- reduction of influence of cough on combined night score [ Time Frame: First and only night of treatment ]All these other elements constitute cough invasiveness into the quality of life of child and parents
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218696
|Contact: Herman A Cohen, Prof.||+ 972-3- email@example.com|
|Contact: Yifat Atias, Dr.||+ 972-3- firstname.lastname@example.org|
|Pediatric Community Ambulatory Clinic - Petach-Tikva|
|Petaẖ Tiqwa, Israel|
|Pediatric Community Ambulatory Clinic|
|Petaẖ Tiqwa, Israel|
|Principal Investigator:||Herman A Cohen, Prof.||Clalit Health Services|